Type 1 Diabetes
Conditions
Keywords
type 1, diabetes, caffeine-enhanced energy drink, cardiac output, glucose, cognitive performance
Brief summary
The aim of this pilot study is to determine the impact of caffeine-enhanced energy drinks on blood glucose excursion on heart rate, blood pressure, cardiac output and cognitive performance in patients with type 1 diabetes. Knowledge acquired may inform a wider study of the impact of these drinks. This is a randomised, cross over blinded study in which all participants will participate in the 3 arms of the study. The study will consist of 3 phases, each lasting 3 days. A different study drink will be administered during each phase. There will be an initial screening visit and a pre- study visit before each study phase. Each participant will make 10 visits to the research centre. There will be a week wash out period between each study phase. Prior to each study phase, there will be a 3 day caffeine and alcohol abstinence run-in period. Study drinks will be matched for taste and volume (as far as possible) and will be administered by the use of opaque cups, lids and straws to enable double-blind randomisation for both researcher and participants. Administration of the study drink to participants will be based on Latin squares to provide a balanced treatment order. During the 3 days study period; participants will be required to abstain from all other caffeine containing beverages or confectioneries. The secondary aim is to determine if tolerance to cardiovascular effects of caffeine-enhanced energy drinks is developed following acute short term ingestion.
Interventions
OTHERCaffeine enhanced energy drink
Comparison of different energy drinks
OTHERGlucose drink
Glucose drink (containing 84mg glucose alone)
Sponsors
The Royal Bournemouth Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female adults aged ≥18 years * Confirmed diagnosis of Type 1 diabetes of more than one year duration * Participants who use multiple daily injections of basal and meal-time analogue insulin. * Ability to perform daily finger stick measurements of blood glucose levels * Adequate contraceptive control * Provision of informed consent
Exclusion criteria
* Hypoglycaemia unawareness * Coronary heart disease * Cardiac arrhythmia * Structural heart lesions, * Autonomic neuropathy * Psychiatry illness, * Epilepsy * Migraine * Caffeine intolerance * Unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in blood glucose level in all patients as a measure of tolerability | Day 1, Day 2 and Day 3 |
Secondary
| Measure | Time frame |
|---|---|
| The effects on certain mood states, e.g. energetic arousal, tense arousal and hedonic tone following the consumption of caffeinated energy drinks in comparison with caffeine free glucose in patients with type 1 diabetes | Day 1, day 2 and day 3 |
| Changes in reaction time and digit symbol substitution test score | Day 1, day 2 and day 3 |
| Changes in heart rate, systolic and diastolic blood pressure in all patients. | Day 1, day 2 and day 3 |
Countries
United Kingdom
Outcome results
None listed